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FDA's analgesic/alcohol interaction case-study comparisons inappropriate, McNeil argues.

This article was originally published in The Tan Sheet

Executive Summary

FDA ANALGESICS/ALCOHOL CASE-STUDY COMPARISONS INAPPROPRIATE, McNEIL Consumer Products argues, "because it is important to recognize that without an explicit comparison group (i.e., a control group), case series and case reports can, at best, only suggest hypotheses for testing in an analytic study with an adequate sample of individuals using an appropriate control group." The Tylenol marketer's assertion comes in Jan. 28 comments to FDA on the agency's Nov. 14 proposed rule requiring alcohol interaction warnings on OTC analgesics/antipyretics for adult use ("The Tan Sheet" Nov. 17, 1997, p. 2). The company believes all OTC analgesics/antipyretics should carry the same alcohol interaction warning.
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